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Deanxit and Rivotril in Tinnitus Patients

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ClinicalTrials.gov Identifier: NCT00841230
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : August 11, 2009
Information provided by:
University Hospital, Antwerp

Brief Summary:
The purpose of this study is to investigate whether increased tinnitus reduction can be obtained with Deanxit in patients already receiving Rivotril.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Deanxit Drug: Lactose placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Additional Value of Deanxit in Tinnitus Patients Treated With Rivotril
Study Start Date : February 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
Drug Information available for: Clonazepam
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Lactose placebo
Drug: Lactose placebo
Lactose used as placebo
Experimental: Deanxit Drug: Deanxit
Deanxit 1x/day

Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 3 weeks, 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pure tone, narrow band noise or polyphonic tinnitus
  • unilateral or bilateral tinnitus
  • VAS ≥ 4

    • cochleair origin tinnitus
    • tinnitus present 3 months or more
    • age 18y or more
    • intake Rivotril 1mg/d
    • patient 'able to cooperate'
    • patient able to fill in TQ en VAS
    • No pontine angle pathology on MRI

Exclusion Criteria:

  • pulsatile tinnitus
  • pregnancy or breast feeding
  • contra-indications Deanxit
  • recovery myocard infarct
  • conduction disorder His
  • untreated glaucoma
  • MAO inhibitors: 15d stop
  • otosclerosis
  • middle ear pathologies
  • Ménière
  • somatic tinnitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841230

Antwerp University Hospital
Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Principal Investigator: Olivier Meeus, MD University Hospital, Antwerp

Responsible Party: Prof Dr P H Van de Heyning, Antwerp University Hospital
ClinicalTrials.gov Identifier: NCT00841230     History of Changes
Other Study ID Numbers: 8/46/260
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by University Hospital, Antwerp:

Additional relevant MeSH terms:
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs